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FDA Inspection
•Coats Aloe International, Inc.•September 18, 2009

Coats Aloe International, Inc. – FDA Inspection, Sep 18, 2009

Record Details

This FDA Inspection record concerns Coats Aloe International, Inc., with an inspection on September 18, 2009, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.

Company
Coats Aloe International, Inc.
Inspection Date
September 18, 2009
Product Type
Food/cosmetics
Office
Center for Food Safety and Applied Nutrition
View Company Profile

ID · 69ec32dc-ef0c-417a-a4e5-6ebeaed336e9

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
613995
FDA center
Foods & Cosmetics
Project area
Foodborne Biological Hazards

FDA Citations

22
  1. 21 CFR 111.325(b)(2)(ii)Records - document; results
  2. 21 CFR 111.210(h)(3)(ii)(B)Components; add, verify
  3. 21 CFR 111.210(h)(5)Corrective action plans
  4. 21 CFR 111.75(a)(1)(i)Component - verify identity, dietary ingredient
  5. 21 CFR 111.25(c)Procedures - equipment - cleaning, sanitizing
  6. 21 CFR 111.303Written procedures - tests, examinations; specifications met
  7. 21 CFR 111.20(c)(1)Physical plant - receiving, holding, identifying
  8. 21 CFR 111.15(c)(3)Cleaning compounds and toxic materials - holding
  9. 21 CFR 111.160(d)(1)Packaging - identify
  10. 21 CFR 111.95(b)(3)Documentation - ensure specifications met

Showing 10 of 22 citations.

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Coats Aloe International, Inc.

3
DateClassificationOfficeProject area
March 4, 2014VAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
July 8, 2011NAICenter for Food Safety and Applied NutritionColors and Cosmetics Technology
January 15, 2010VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Coats Aloe International, Inc.
  • FDA Inspection 866493 - 2014-03-04
  • FDA Inspection 733811 - 2011-07-08
  • FDA Inspection 646088 - 2010-01-15

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